MUNICH, & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Rigontec, the leader in RIG-I targeting RNA therapeutics, today announced the dosing of the first patient in a phase I/II study with intratumoral/intralesional administration of its lead compound RGT100 in solid tumors and lymphoma. RGT100 targets the retinoic acid-inducible gene I (RIG-I) pathway, one of the most essential pathways in the innate immune system to induce both immediate and long-term anti-tumor immunity. Targeting RIG-I is a novel and distinct approach in cancer immuno-therapy which has demonstrated substantial local and systemic tumor regression in several relevant in vivo models. Rigontec has been spearheading efforts to access this pathway to develop new treatment options and this study will be the first to test the approach in patients.
In parallel, Rigontec announces the appointment of industry veteran Prof. Eugen Leo as Chief Medical Officer. Prof. Leo brings to Rigontec more than 15 years of experience in conducting phase I-III development of innovative anti-cancer compounds such as kinase inhibitors, antibodies, vaccines and antisense molecules, with a major focus on immuno-oncology. He will lead the global clinical development of RGT100 and will report to Dr. Christian Schetter, CEO of Rigontec.
“Rigontec has achieved entry into the clinic within three years since our foundation as a company, which not only is a testament to our scientific founders who have pioneered the approach, but also to our focus and commitment to bring this exciting approach forward,” said Christian Schetter, CEO of Rigontec. “We enjoy a first mover position in this pathway and look forward to initial results. Having Eugen join Rigontec with his profound developmental experience at this significant stage to support our clinical progress is very valuable and we are pleased to welcome him to the team.”
The first-in-human study of a RIG-I agonist (RGT100-001; ClinicalTrials.gov Identifier: NCT03065023) is designed to assess safety, tolerability and pharmacokinetics of RGT100 in patients with injectable solid tumor lesions. The multi-center study is conducted in immuno-oncology experienced centers in the United Kingdom, Spain, France and Germany and will include a dose-escalation part as well as several expansion arms.
“I am delighted to join Rigontec at this point in time. Targeting the innate immune system via RIG-I has the potential to open up a completely new chapter in immuno-oncology”, said Eugen Leo, the new CMO of Rigontec. “We aim to demonstrate in this phase I/II trial that RIG-I activation can not only engage the innate immune system to safely eliminate cancer cells in patients, but also that this new treatment modality can be combined effectively with existing successful immuno-oncology treatments.”
Dr. Eugen Leo is a board-certified Hematologist and Medical Oncologist, Professor of Medicine and targeted therapy development specialist. Previously, he served in various positions with growing responsibilities up to Vice President level within both biotechnology (Micromet) and large pharmaceutical companies (Johnson&Johnson, Merck-Serono). He has been instrumental for reaching proof-of-concept for the BiTE platform (blinatumomab) and development of various other first-in class molecules in the immuno-oncology space. He studied medicine at the Universities of Freiburg, Münster, Heidelberg (Germany) and Cincinnati (USA). Dr. Leo is ESMO-certified, holds an M.B.A. from Colorado State University, is founder of LeoConsulting/Munich and currently also serves as Head of Clinical Development for Isarna Therapeutics GmbH, Munich.
Rigontec is the leader in RIG-I targeting therapeutics. Utilizing our proprietary RIG-I agonist platform, we harness one of the most essential pathways in the innate immune system to pioneer a novel immuno-oncology treatment approach. Rigontec’s proprietary agonists specifically activate RIG-I, inducing both immediate and long-term anti-tumor immunity and have proven substantial local and systemic tumor regression in several relevant in vivo models. In addition to malignant diseases, our innovative bifunctional RNA molecules can be developed for the treatment of infectious and inflammatory diseases.